Invivyd Announces Preliminary Fourth Quarter 2024 Financial Results, Strong Revenue Growth, and Reiterates Goal of Near-Term Profitability
Invivyd (IVVD) announced preliminary Q4 2024 financial results, showing strong growth with PEMGARDA™ net product revenue of $13.8 million, a 48% increase from Q3 2024's $9.3 million. The company significantly reduced operating costs to $32 million in Q4, down 55% from Q3's $71.6 million, primarily through manufacturing expense reductions.
The company ended 2024 with $69.3 million in cash and cash equivalents plus $10.9 million in accounts receivable. Invivyd expects minimal manufacturing expenses in 2025, as VYD2311 commercial manufacturing was completed in 2024 to support up to one million doses. The company maintains its target for near-term profitability by the end of 1H 2025, supported by existing cash, anticipated revenue growth, and continued cost reductions.
Invivyd (IVVD) ha annunciato i risultati finanziari preliminari del quarto trimestre 2024, mostrando una forte crescita con entrate nette del prodotto PEMGARDA™ pari a 13,8 milioni di dollari, un aumento del 48% rispetto ai 9,3 milioni di dollari del terzo trimestre 2024. L'azienda ha significativamente ridotto i costi operativi a 32 milioni di dollari nel quarto trimestre, con una diminuzione del 55% rispetto ai 71,6 milioni di dollari del terzo trimestre, principalmente grazie alla riduzione delle spese di produzione.
L'azienda ha chiuso il 2024 con 69,3 milioni di dollari in contanti e disponibilità liquide più 10,9 milioni di dollari di crediti verso i clienti. Invivyd prevede spese di produzione minime nel 2025, poiché la produzione commerciale di VYD2311 è stata completata nel 2024 per supportare fino a un milione di dosi. L'azienda mantiene il suo obiettivo di raggiungere la redditività a breve termine entro la fine del primo semestre 2025, supportata dalla liquidità esistente, dalla crescita attesa delle entrate e dalla continua riduzione dei costi.
Invivyd (IVVD) anunció resultados financieros preliminares para el cuarto trimestre de 2024, mostrando un fuerte crecimiento con ingresos netos por producto PEMGARDA™ de 13,8 millones de dólares, un aumento del 48% respecto a los 9,3 millones de dólares del tercer trimestre de 2024. La empresa redujo significativamente los costos operativos a 32 millones de dólares en el cuarto trimestre, una disminución del 55% respecto a los 71,6 millones de dólares del tercer trimestre, principalmente a través de la reducción de gastos de fabricación.
La empresa cerró 2024 con 69,3 millones de dólares en efectivo y equivalentes de efectivo más 10,9 millones de dólares en cuentas por cobrar. Invivyd espera gastos de fabricación mínimos en 2025, ya que la fabricación comercial de VYD2311 se completó en 2024 para respaldar hasta un millón de dosis. La empresa mantiene su objetivo de rentabilidad a corto plazo para finales del primer semestre de 2025, respaldado por efectivo existente, crecimiento anticipado de ingresos y reducciones continuas de costos.
Invivyd (IVVD)는 2024년 4분기 재무 결과를 발표하였으며, PEMGARDA™의 순 제품 수익이 1,380만 달러로 2024년 3분기의 930만 달러에 비해 48% 증가하며 강력한 성장을 보여주고 있습니다. 회사는 운영 비용을 4분기에 3,200만 달러로 크게 줄였으며, 이는 3분기의 7,160만 달러에서 55% 감소한 것입니다. 이는 주로 제조 비용 절감을 통해 이루어졌습니다.
회사는 2024년을 현금 및 현금성 자산으로 6,930만 달러와 1,090만 달러의 매출 채권으로 마감했습니다. Invivyd는 2025년에 최소한의 제조 비용을 예상하며, VYD2311의 상업적 생산이 2024년에 완료되어 최대 100만 도스를 지원하게 됩니다. 회사는 기존 현금, 예상되는 수익 성장 및 지속적인 비용 절감을 바탕으로 2025년 상반기 말까지 단기 수익성 목표를 유지하고 있습니다.
Invivyd (IVVD) a annoncé des résultats financiers préliminaires pour le quatrième trimestre 2024, montrant une forte croissance avec un chiffre d'affaires net du produit PEMGARDA™ s'élevant à 13,8 millions de dollars, soit une augmentation de 48 % par rapport aux 9,3 millions de dollars du troisième trimestre 2024. L'entreprise a considérablement réduit ses coûts d'exploitation à 32 millions de dollars au quatrième trimestre, soit une diminution de 55 % par rapport aux 71,6 millions de dollars du troisième trimestre, principalement grâce à des réductions de dépenses de fabrication.
L'entreprise a terminé 2024 avec 69,3 millions de dollars en espèces et équivalents de trésorerie ainsi que 10,9 millions de dollars de créances clients. Invivyd prévoit des dépenses de fabrication minimales en 2025, car la production commerciale de VYD2311 a été réalisée en 2024 pour soutenir jusqu'à un million de doses. L'entreprise maintient son objectif de rentabilité à court terme d'ici la fin du premier semestre 2025, soutenue par la trésorerie existante, la croissance anticipée des revenus et la poursuite des réductions de coûts.
Invivyd (IVVD) gab die vorläufigen finanziellen Ergebnisse für das 4. Quartal 2024 bekannt und zeigte ein starkes Wachstum mit PEMGARDA™ Nettoumsatz von 13,8 Millionen Dollar, was einem Anstieg von 48% im Vergleich zu den 9,3 Millionen Dollar im 3. Quartal 2024 entspricht. Das Unternehmen reduzierte die Betriebskosten deutlich auf 32 Millionen Dollar im 4. Quartal, ein Rückgang von 55% im Vergleich zu 71,6 Millionen Dollar im 3. Quartal, hauptsächlich durch Reduzierung der Herstellungskosten.
Das Unternehmen beendete 2024 mit 69,3 Millionen Dollar in Bar- und Baräquivalenten sowie 10,9 Millionen Dollar aus Forderungen. Invivyd erwartet im Jahr 2025 minimale Herstellungskosten, da die kommerzielle Herstellung von VYD2311 im Jahr 2024 abgeschlossen wurde, um bis zu einer Million Dosen zu unterstützen. Das Unternehmen hält an seinem Ziel fest, bis Ende des ersten Halbjahres 2025 kurzfristig rentabel zu sein, unterstützt durch vorhandenes Bargeld, voraussichtliches Umsatzwachstum und kontinuierliche Kostensenkungen.
- 48% quarter-over-quarter revenue growth to $13.8M in Q4 2024
- 55% reduction in operating expenses to $32M in Q4 2024
- Strong cash position of $69.3M plus $10.9M in receivables
- Completed manufacturing for up to 1M doses of VYD2311
- Minimal manufacturing expenses expected for 2025
- Still operating at a loss despite revenue growth
- Significant dependence on PEMGARDA revenue growth for reaching profitability
Insights
The preliminary Q4 results reveal a compelling financial transformation at Invivyd. The 48% sequential revenue growth to
The dramatic 55% reduction in operating expenses to
The robust balance sheet with
Key factors supporting near-term profitability include:
- Minimal manufacturing expenses expected in 2025
- Strong PEMGARDA revenue momentum
- Completed VYD2311 manufacturing investment
- Substantial accounts receivable conversion to cash
- Preliminary Q4 2024 PEMGARDA™ (pemivibart) net product revenue of
$13.8 million ,48% growth over Q3 2024 net product revenue of$9.3 million - Preliminary Q4 2024 total operating costs and expenses of approximately
$32 million ,55% reduction compared to Q3 2024 operating costs and expenses of$71.6 million - Preliminary ending 2024 cash and cash equivalents of
$69.3 million and$10.9 million of accounts receivable - Continues to target near-term (by end of 1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, and continued reduction of manufacturing expenses
- Further update to be provided on Q4 2024 earnings call anticipated in late March in conjunction with Form 10-K filing
WALTHAM, Mass., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced preliminary fourth quarter (Q4) financial results.
Invivyd previously guided expectations to finish 2024 with
Based on currently available information, the company is announcing preliminary Q4 2024 PEMGARDA™ (pemivibart) net product revenue of
"We are pleased with continued strong top-line revenue growth and execution toward near-term profitability," noted Bill Duke, Chief Financial Officer of Invivyd. "With a strong balance sheet, anticipated continued growth in revenues and simultaneous reduction in operating expenses, we are well-positioned to support PEMGARDA commercial efforts and look forward to the future of VYD2311."
About PEMGARDA
PEMGARDA™ (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd's investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1 and XEC. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
PEMGARDA is not authorized for use for treatment of COVID-19 or post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccinations, should receive COVID-19 vaccination. In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination.
Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse events (all grades, incidence ≥
To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants.
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to
About VYD2311
VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.
VYD2311 was engineered using Invivyd's proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd's investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd's investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more.
Cautionary Statement Regarding Preliminary Financial Results
The preliminary financial results for the fourth quarter 2024 included in this press release are preliminary, unaudited and subject to completion. Such preliminary results are subject to the finalization of quarter-end financial and accounting procedures, and actual results may vary from the preliminary results presented herein. The preliminary financial results represent management’s estimates that constitute forward-looking statements subject to certain risks and uncertainties. These preliminary estimates have not been audited by the company’s independent registered public accounting firm.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "could," "expects," "estimates," "intends," "potential," "predicts," "projects," and "future" or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the company's preliminary fourth quarter financial results; the company's goal of near-term profitability; the company's expectations regarding anticipated net product revenue growth, continued reduction of manufacturing expenses, and operational efficiency improvements; the company's beliefs about its position to support PEMGARDA commercial efforts and the future of VYD2311; the potential of PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise; the potential of VYD2311 as a novel mAb candidate and the potential of VYD2311 to deliver clinically meaningful titer levels through more patient-friendly means; the company's devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company's forward-looking statements and you should not place undue reliance on the company's forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: uncertainties regarding the company's expectations, projections and estimates regarding future costs and expenses, future revenue, capital requirements, and the availability of and the need for additional financing; whether the company's cash and cash equivalents are sufficient to support its operating plan for as long as anticipated; uncertainties regarding market acceptance, payor coverage or future revenue generated by PEMGARDA; uncertainties regarding the potential advantages from the company's planned operational efficiency improvements; the timing, progress and results of the company's discovery, preclinical and clinical development activities; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company's product candidates based on neutralizing activity in nonclinical studies; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitope that pemivibart and VYD2311 targets remains structurally intact; whether the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; changes in the regulatory environment; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; clinical trial site activation or enrollment rates; how long the EUA granted by the FDA for PEMGARDA will remain in effect and whether the EUA is revised or revoked by the FDA; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; the company's ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; changes in expected or existing competition; the company's reliance on third parties; any change in the preliminary estimates of the company's Q4 2024 results upon completion of the company's financial closing controls and procedures, and finalization of the financial statements; the company's ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended December 31, 2023 and the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, each filed with the Securities and Exchange Commission (SEC), and in the company's other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.
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Contacts:
Media Relations
(781) 208-1747
media@invivyd.com
Investor Relations
(781) 208-1747
investors@invivyd.com
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